Intravascular ultraSound (IVUS) Imaging During transvEnous Lead Extraction (ISEE)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Chicago
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- IVUS Grades
Study Overview
Brief Summary
The purpose of this study is to prospectively evaluate intravascular ultrasound (IVUS) imaging as a tool for grading the presence and characterization of intravascular lead adherence (ILA, or scarring) to cardiovascular implantable electronic device (CIED) leads during transvenous lead extraction (TLE) procedures in a multi-center study. IVUS should identify the location and severity of these adhesions, which the investigators will then correlate to difficulty of the extraction procedure using metrics like pulses of laser energy delivered and time required to traverse an area of fibrosis or ILA. The investigators will be focusing primarily on the section from innominate vein (INNV) down through the superior vena cava (SVC) to the right atrium.
Using IVUS to view blood vessels and the heart structure is approved by the Food and Drug Administration (FDA). Using it as described in this study is off label because of the manner in which it is advanced to the SVC, through the right atrium. While it is not restricted from use in this way, it is not specifically on-label. It should be noted that the use of IVUS during TLE procedures as proposed in this study is routine at the University of Chicago and patients will undergo this procedure regardless of participation in this study. The EP physician team regards the use of IVUS during TLE to be nonsignificant risk.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients at least 21 years of age
- •Patients with at least one lead over 1 year dwell time requiring extraction
Exclusion Criteria
- •Inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity
- •Venous occlusion to the extent that the IVUS catheter cannot pass
- •Leads < 1 year dwell time requiring extraction
Arms & Interventions
IVUS imaging
IVUS imaging will be used each patient undergoing transvenous lead extraction to visualize ILA
Intervention: IVUS Imaging (Device)
Outcomes
Primary Outcomes
IVUS Grades
Time Frame: 6 hours
Operators will be able to successfully grade the degree of intravascular lead adherence (ILA) seen using IVUS imaging. Using the following scale, grading of ILA in each zone of interest, based on relative motion of lead will be performed: i. Grade 1: Freely mobile, Rarely adjacent to vasculature ii. Grade 2: Restricted mobility, Frequently adjacent to vasculature iii. Grade 3: Immobile, Always adjacent to vasculature iv. Grade L, added to number: Lead-to-lead binding
Secondary Outcomes
- Extraction Difficulty Metrics(Through study completion, expected to be 6 months)